Understanding Medical Device Manufacturing License in India

The Government of India regulates the manufacturing of medical devices under the Medical Devices Rules, 2017, which are governed by the Central Drugs Standard Control Organization (CDSCO) and respective State Licensing Authorities (SLAs).

Manufacturers are required to obtain:

• Form MD-5 License – for Class A and Class B devices (granted by SLA)
• Form MD-9 License – for Class C and Class D devices (granted by CDSCO)

The licensing framework is designed based on a risk classification model:

• Class A – Low Risk
• Class B – Low to Moderate Risk
• Class C – Moderate to High Risk
• Class D – High Risk

Each classification requires a different level of regulatory scrutiny, technical documentation, and quality system implementation.

Our Role – How Rico Solutions Simplifies the Licensing Process

At Rico Solutions India Private Limited, we don’t just offer documentation support—we partner with you in building a compliant, efficient, and certified medical device manufacturing operation. From start to finish, our regulatory consultants walk you through every stage of the licensing journey.

Our Services Include:

1. Device Classification & Regulatory Consultation

• Assessment of your product’s classification under Indian MDR, 2017
• Identification of applicable forms, standards, and documentation
• Advice on regulatory pathway, timelines, and certification strategy

2. Site Readiness and Infrastructure Evaluation

• Analysis of your proposed or existing manufacturing unit
• Recommendations for layout planning, workflow design, and equipment
• Guidance on creating controlled environments (where required)

3. Quality Management System (QMS) Support

• Implementation of ISO 13485:2016 or equivalent QMS framework
• Internal audits and gap analysis
• SOP development and validation support
• Staff training and documentation compliance

4. Dossier Preparation

• Preparation of:
  • Device Master File (DMF)
  • Plant Master File (PMF)
• Compilation of technical documentation as per MDR, 2017
• Risk management files, clinical evidence, and labeling documentation

5. Application Filing and Coordination

• Filing Form MD-3 (application for MD-5/MD-9 license)
• Payment of regulatory fees and coordination with authorities
• Representation before CDSCO or State Authority
• Scheduling and preparation for facility inspection

6. Facility Audit Preparation

• Mock audits to ensure 100% readiness
• Addressing compliance gaps before the official inspection
• On-site or virtual support during audit days

7. Post-License Support

• Product endorsement under the same license
• Post-approval changes (PAC)
• License renewal, expansion, and regulatory advisory
• Technical updates based on amendments in MDR

Documents Required for Medical Device Manufacturing License

To ensure a smooth approval process, we help clients organize and verify the following documents:

• Application Form (MD-3)
• Valid ISO 13485 certificate
• Detailed site layout and design
• List of manufacturing and testing equipment
• Qualifications of key technical staff
• Device Master File (DMF)
• Plant Master File (PMF)
• SOPs and quality control procedures
• Environment safety measures (where applicable)
• Utilities and HVAC details (for critical environments)
• Product label samples

Who Needs a Medical Device Manufacturing License?

The license is mandatory for:

• New manufacturers setting up medical device production
• Companies transitioning from voluntary compliance to mandatory licensing
• OEMs and contract manufacturers producing under third-party brand names
• Startups developing diagnostic kits or low-risk equipment
• Manufacturers of surgical, dental, ophthalmic, and implantable devices

Classes of Devices We Support

Class A Devices (Low Risk)

• Examples: Examination gloves, tongue depressors, surgical dressing kits
• Processed by State Licensing Authority (SLA)

Class B Devices (Moderate Risk)

• Examples: Blood pressure monitors, infusion sets, thermometers
• Processed by SLA with slightly more documentation

Class C Devices (High Risk)

• Examples: Ultrasound machines, anesthesia systems
• Evaluated by CDSCO and require stricter scrutiny

Class D Devices (Critical Risk)

• Examples: Heart valves, implantable defibrillators, pacemakers
• Processed entirely by CDSCO with full audits and clinical evidence

No matter the class, Rico Solutions ensures you meet the regulatory benchmarks for quality, safety, and efficacy.

Why Choose Rico Solutions India Private Limited?

Proven Track Record

We’ve helped dozens of manufacturers across India acquire their MD-5 and MD-9 licenses efficiently, with minimal rejections or queries.

Technical Expertise

Our team includes biomedical engineers, regulatory strategists, and quality system experts who understand both product innovation and compliance.

End-to-End Support

We’re with you from plant design to license receipt—and beyond. Our 360-degree service ensures that nothing is left to chance.

Audit-Ready Preparation

We conduct internal inspections and provide checklists, templates, and corrective measures that help you sail through regulatory audits with ease.

Cost-Effective Solutions

Our services are priced competitively, keeping MSMEs, small manufacturers, and startups in mind—without compromising on quality.

Frequently Asked Questions (FAQs)

Q1. Is ISO 13485 certification mandatory for manufacturing licenses?

Yes. A valid ISO 13485 certificate is required as proof of a functional quality management system in your manufacturing setup.

Q2. How long does it take to get the license?

For Class A/B devices: approx. 6–8 weeks.
For Class C/D devices: approx. 3–6 months, depending on the audit and documentation readiness.

Q3. Can a single manufacturing unit hold licenses for multiple devices?

Yes. Multiple products can be endorsed under the same license if the facility and QMS support it.

Q4. Is the license valid for a lifetime?

The license remains valid as long as you pay the prescribed retention fee every 5 years and continue to comply with MDR, 2017.

Q5. Do I need clinical data for manufacturing license?

Not always. For Class A and B devices, clinical data may not be required. However, for Class C and D, clinical evidence or performance evaluation data may be mandatory.

Industries & Segments We Serve

We’ve helped clients manufacture:

• Diagnostic kits (rapid test, IVD devices)
• Hospital equipment (beds, sterilizers, monitors)
• Orthopedic implants
• Cardiology and neurology devices
• Disposable surgical tools
• Dental products
• Ophthalmic instruments

From basic Class A products to critical Class D devices, Rico Solutions supports a wide variety of product portfolios with dedicated licensing pathways.

Partner With Rico Solutions Today

India’s push for Make in India, combined with global demand for reliable and affordable medical devices, presents a golden opportunity for manufacturers. But success in this regulated industry starts with the right compliance and licensing foundation.

Let Rico Solutions India Private Limited be your trusted partner in obtaining a Medical Device Manufacturing License that enables your business to thrive. With us, you don’t just meet compliance—you build credibility, reliability, and trust in your product.